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Volumn 36, Issue 3, 2013, Pages 183-197

Postmarketing safety surveillance: Where does signal detection using electronic healthcare records fit into the big picture?

Author keywords

[No Author keywords available]

Indexed keywords

ALOSETRON; APROTININ; CERIVASTATIN; CISAPRIDE; DEXTROPROPOXYPHENE; EFALIZUMAB; ETRETINATE; FANOLESOMAB TC 99M; GEMTUZUMAB OZOGAMICIN; LEVACETYLMETHADOL; LUMIRACOXIB; MEDIDIA; NATALIZUMAB; PEMOLINE MAGNESIUM; PERGOLIDE; RAPACURONIUM BROMIDE; RIMONABANT; ROFECOXIB; ROSIGLITAZONE; SIBUTRAMINE; TEGASEROD; THIORIDAZINE; TROGLITAZONE; TROVAFLOXACIN; TURVEL; UNCLASSIFIED DRUG; VALDECOXIB; XIMELAGATRAN;

EID: 84876575913     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.1007/s40264-013-0018-x     Document Type: Review
Times cited : (80)

References (107)
  • 1
    • 11244278062 scopus 로고    scopus 로고
    • Challenges to evidence-based medicine: A comparison of patients and treatments in randomized controlled trials with patients and treatments in a practice research network
    • 15624072 10.1007/s00127-005-0838-9
    • Zarin DA, Young JL, West JC. Challenges to evidence-based medicine: a comparison of patients and treatments in randomized controlled trials with patients and treatments in a practice research network. Soc Psychiatry Psychiatr Epidemiol. 2005;40(1):27-35.
    • (2005) Soc Psychiatry Psychiatr Epidemiol , vol.40 , Issue.1 , pp. 27-35
    • Zarin, D.A.1    Young, J.L.2    West, J.C.3
  • 2
    • 0037067884 scopus 로고    scopus 로고
    • Representation of the elderly, women, and minorities in heart failure clinical trials
    • 12153370 10.1001/archinte.162.15.1682
    • Heiat A, Gross CP, Krumholz HM. Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med. 2002;162(15):1682-8.
    • (2002) Arch Intern Med , vol.162 , Issue.15 , pp. 1682-1688
    • Heiat, A.1    Gross, C.P.2    Krumholz, H.M.3
  • 3
    • 0029912547 scopus 로고    scopus 로고
    • Why we need observational studies to evaluate the effectiveness of health care
    • 8634569 10.1136/bmj.312.7040.1215 1:STN:280:DyaK283hsVGluw%3D%3D
    • Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ. 1996;312(7040):1215-8.
    • (1996) BMJ , vol.312 , Issue.7040 , pp. 1215-1218
    • Black, N.1
  • 4
    • 33644752689 scopus 로고    scopus 로고
    • Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies
    • 16505459
    • Papanikolaou PN, Christidi GD, Ioannidis JP. Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies. CMAJ. 2006;174(5):635-41.
    • (2006) CMAJ , vol.174 , Issue.5 , pp. 635-641
    • Papanikolaou, P.N.1    Christidi, G.D.2    Ioannidis, J.P.3
  • 7
    • 0038109711 scopus 로고    scopus 로고
    • Stroke associated with sympathomimetics contained in over-the-counter cough and cold drugs
    • 12791938 10.1161/01.STR.0000075293.45936.FA 1:CAS:528: DC%2BD3sXkvFyjtbs%3D
    • Cantu C, Arauz A, Murillo-Bonilla LM, et al. Stroke associated with sympathomimetics contained in over-the-counter cough and cold drugs. Stroke. 2003;34(7):1667-72.
    • (2003) Stroke , vol.34 , Issue.7 , pp. 1667-1672
    • Cantu, C.1    Arauz, A.2    Murillo-Bonilla, L.M.3
  • 8
    • 80053307147 scopus 로고    scopus 로고
    • Cardiovascular risk with non-steroidal anti-inflammatory drugs: Systematic review of population-based controlled observational studies
    • 21980265 10.1371/journal.pmed.1001098 1:CAS:528:DC%2BC3MXhtlCjsrnE
    • McGettigan P, Henry D. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. PLoS Med. 2011;8(9):e1001098.
    • (2011) PLoS Med , vol.8 , Issue.9 , pp. 1001098
    • McGettigan, P.1    Henry, D.2
  • 9
    • 0038931405 scopus 로고    scopus 로고
    • Bayesian data mining in large frequency tables, with an application to the FDA Spontaneous Reporting System
    • DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA Spontaneous Reporting System. Am Stat. 1999;53:177-202.
    • (1999) Am Stat , vol.53 , pp. 177-202
    • Dumouchel, W.1
  • 10
    • 0042413852 scopus 로고    scopus 로고
    • Disproportionality analysis using empirical Bayes data mining: A tool for the evaluation of drug interactions in the post-marketing setting
    • 14513665 10.1002/pds.885
    • Almenoff JS, DuMouchel W, Kindman LA, et al. Disproportionality analysis using empirical Bayes data mining: a tool for the evaluation of drug interactions in the post-marketing setting. Pharmacoepidemiol Drug Saf. 2003;12(6):517-21.
    • (2003) Pharmacoepidemiol Drug Saf , vol.12 , Issue.6 , pp. 517-521
    • Almenoff, J.S.1    Dumouchel, W.2    Kindman, L.A.3
  • 11
    • 0037221866 scopus 로고    scopus 로고
    • Quantitative methods in pharmacovigilance: Focus on signal detection
    • 12580646 10.2165/00002018-200326030-00003
    • Hauben M, Zhou X. Quantitative methods in pharmacovigilance: focus on signal detection. Drug Saf. 2003;26(3):159-86.
    • (2003) Drug Saf , vol.26 , Issue.3 , pp. 159-186
    • Hauben, M.1    Zhou, X.2
  • 12
    • 22544439665 scopus 로고    scopus 로고
    • Implementation of automated signal generation in pharmacovigilance using a knowledge-based approach
    • 15955732 10.1016/j.ijmedinf.2005.04.006
    • Bousquet C, Henegar C, Louet AL, et al. Implementation of automated signal generation in pharmacovigilance using a knowledge-based approach. Int J Med Inform. 2005;74(7-8):563-71.
    • (2005) Int J Med Inform , vol.74 , Issue.7-8 , pp. 563-571
    • Bousquet, C.1    Henegar, C.2    Louet, A.L.3
  • 13
    • 84861051720 scopus 로고    scopus 로고
    • Data mining techniques in pharmacovigilance
    • Hartzema AG, Tilson HH, Chan KA, editors Cincinnati: Harvey Whitney
    • Bate A, Edwards IR. Data mining techniques in pharmacovigilance. In: Hartzema AG, Tilson HH, Chan KA, editors. Pharmacoepidemiology and therapeutic risk management. Cincinnati: Harvey Whitney; 2008.
    • (2008) Pharmacoepidemiology and Therapeutic Risk Management
    • Bate, A.1    Edwards, I.R.2
  • 14
    • 0036307463 scopus 로고    scopus 로고
    • Signal generation in the New Zealand Intensive Medicines Monitoring Programme: A combined clinical and statistical approach
    • 12071780 10.2165/00002018-200225060-00007 1:CAS:528:DC%2BD38XlslOit74%3D
    • Coulter D. Signal generation in the New Zealand Intensive Medicines Monitoring Programme: a combined clinical and statistical approach. Drug Saf. 2002;25(6):433-9.
    • (2002) Drug Saf , vol.25 , Issue.6 , pp. 433-439
    • Coulter, D.1
  • 15
    • 0036303214 scopus 로고    scopus 로고
    • Automated signal generation in prescription-event monitoring
    • 12071779 10.2165/00002018-200225060-00006
    • Heeley E, Wilton LV, Shakir SA. Automated signal generation in prescription-event monitoring. Drug Saf. 2002;25(6):423-32.
    • (2002) Drug Saf , vol.25 , Issue.6 , pp. 423-432
    • Heeley, E.1    Wilton, L.V.2    Shakir, S.A.3
  • 16
    • 68849085448 scopus 로고    scopus 로고
    • The new Sentinel Network: Improving the evidence of medical-product safety
    • 19635947 10.1056/NEJMp0905338 1:CAS:528:DC%2BD1MXpvFOjtrg%3D
    • Platt R, Wilson M, Chan KA, et al. The new Sentinel Network: improving the evidence of medical-product safety. N Engl J Med. 2009;361(7):645-7.
    • (2009) N Engl J Med , vol.361 , Issue.7 , pp. 645-647
    • Platt, R.1    Wilson, M.2    Chan, K.A.3
  • 17
    • 78650362198 scopus 로고    scopus 로고
    • Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: The EU-ADR Project
    • 21182150 10.1002/pds.2053
    • Coloma PM, Schuemie MJ, Trifiro G, et al. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf. 2011;20(1):1-11.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , Issue.1 , pp. 1-11
    • Coloma, P.M.1    Schuemie, M.J.2    Trifiro, G.3
  • 20
    • 60749099873 scopus 로고    scopus 로고
    • Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions
    • 19236117 10.2165/00002018-200932020-00003
    • Hauben M, Aronson JK. Defining 'signal' and its subtypes in pharmacovigilance based on a systematic review of previous definitions. Drug Saf. 2009;32(2):99-110.
    • (2009) Drug Saf , vol.32 , Issue.2 , pp. 99-110
    • Hauben, M.1    Aronson, J.K.2
  • 21
    • 84872331521 scopus 로고    scopus 로고
    • US FDA Accessed 2013 Jan 9
    • US FDA. FDA Adverse Event Reporting System (AERS). Available from URL: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ AdverseDrugEffects/default.htm. Accessed 2013 Jan 9.
    • FDA Adverse Event Reporting System (AERS)
  • 22
  • 23
    • 84876552130 scopus 로고    scopus 로고
    • European Medicines Agency Accessed 9 Jan 2013
    • European Medicines Agency. EudraVigilance. Available from URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document-listing/ document-listing-000239.jsp&mid=WC0b01ac05800250b5. Accessed 9 Jan 2013.
    • EudraVigilance
  • 24
    • 84876523534 scopus 로고    scopus 로고
    • European Medicines Agency Accessed 9 Jan 2013
    • European Medicines Agency. 2009 EudraVigilance-human status report. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/Report/ 2010/10/WC500097692.pdf. Accessed 9 Jan 2013.
    • 2009 EudraVigilance-human Status Report
  • 25
    • 84876559902 scopus 로고    scopus 로고
    • The Uppsala Monitoring Centre Accessed 20 Apr 2012
    • The Uppsala Monitoring Centre. The WHO programme. Available from URL: http://www.who-umc.org/DynPage.aspx?id=98078&mn1=7347&mn2=7252&mn3= 7322. Accessed 20 Apr 2012.
    • The WHO Programme
  • 26
    • 77951676395 scopus 로고    scopus 로고
    • Uppsala Monitoring Centre 2012 April Accessed 29 May 2012
    • Uppsala Monitoring Centre. Uppsala reports, 2012 April. Available from URL: http://www.who-umc.org/graphics/26656.pdf. Accessed 29 May 2012.
    • Uppsala Reports
  • 27
    • 76949087715 scopus 로고    scopus 로고
    • Stronger association of drug-induced progressive multifocal leukoencephalopathy (PML) with biological immunomodulating agents
    • 19838692 10.1007/s00228-009-0739-z 1:CAS:528:DC%2BC3cXkt1KisA%3D%3D
    • Piccinni C, Sacripanti C, Poluzzi E, et al. Stronger association of drug-induced progressive multifocal leukoencephalopathy (PML) with biological immunomodulating agents. Eur J Clin Pharmacol. 2010;66(2):199-206.
    • (2010) Eur J Clin Pharmacol , vol.66 , Issue.2 , pp. 199-206
    • Piccinni, C.1    Sacripanti, C.2    Poluzzi, E.3
  • 29
    • 4344717733 scopus 로고    scopus 로고
    • Pharmacovigilance in the 21st century: New systematic tools for an old problem
    • 15460169 10.1592/phco.24.13.1099.38090
    • Szarfman A, Tonning JM, Doraiswamy PM. Pharmacovigilance in the 21st century: new systematic tools for an old problem. Pharmacotherapy. 2004;24(9):1099-104.
    • (2004) Pharmacotherapy , vol.24 , Issue.9 , pp. 1099-1104
    • Szarfman, A.1    Tonning, J.M.2    Doraiswamy, P.M.3
  • 30
    • 24344432126 scopus 로고    scopus 로고
    • The role of data mining in pharmacovigilance
    • 16111454 10.1517/14740338.4.5.929 1:CAS:528:DC%2BD2MXpslejurs%3D
    • Hauben M, Madigan D, Gerrits CM, et al. The role of data mining in pharmacovigilance. Expert Opin Drug Saf. 2005;4(5):929-48.
    • (2005) Expert Opin Drug Saf , vol.4 , Issue.5 , pp. 929-948
    • Hauben, M.1    Madigan, D.2    Gerrits, C.M.3
  • 31
    • 0035700740 scopus 로고    scopus 로고
    • Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports
    • 10.1002/pds.677 1:STN:280:DC%2BD38%2FpvFWqsA%3D%3D
    • Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoeidemiol Drug Saf. 2001;10(6):483-6.
    • (2001) Pharmacoeidemiol Drug Saf , vol.10 , Issue.6 , pp. 483-486
    • Evans, S.J.1    Waller, P.C.2    Davis, S.3
  • 32
    • 4544368008 scopus 로고    scopus 로고
    • The reporting odds ratio and its advantages over the proportional reporting ratio
    • 15317031 10.1002/pds.1001
    • Rothman KJ, Lanes S, Sacks ST. The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf. 2004;13(8):519-23.
    • (2004) Pharmacoepidemiol Drug Saf , vol.13 , Issue.8 , pp. 519-523
    • Rothman, K.J.1    Lanes, S.2    Sacks, S.T.3
  • 33
    • 0036300732 scopus 로고    scopus 로고
    • Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database
    • 12071774 10.2165/00002018-200225060-00001 1:CAS:528:DC%2BD38XlslOitrY%3D
    • Szarfman A, Machado SG, O'Neill RT. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database. Drug Saf. 2002;25(6):381-92.
    • (2002) Drug Saf , vol.25 , Issue.6 , pp. 381-392
    • Szarfman, A.1    Machado, S.G.2    O'Neill, R.T.3
  • 34
    • 0036307462 scopus 로고    scopus 로고
    • A data mining approach for signal detection and analysis
    • 12071775 10.2165/00002018-200225060-00002 1:CAS:528:DC%2BD38XlslOitrc%3D
    • Bate A, Lindquist M, Edwards IR, et al. A data mining approach for signal detection and analysis. Drug Saf. 2002;25(6):393-7.
    • (2002) Drug Saf , vol.25 , Issue.6 , pp. 393-397
    • Bate, A.1    Lindquist, M.2    Edwards, I.R.3
  • 35
    • 33846665203 scopus 로고    scopus 로고
    • Potential use of data-mining algorithms for the detection of 'surprise' adverse drug reactions
    • 17253879 10.2165/00002018-200730020-00004
    • Hauben M, Horn S, Reich L. Potential use of data-mining algorithms for the detection of 'surprise' adverse drug reactions. Drug Saf. 2007;30(2):143-55.
    • (2007) Drug Saf , vol.30 , Issue.2 , pp. 143-155
    • Hauben, M.1    Horn, S.2    Reich, L.3
  • 36
    • 84859213965 scopus 로고    scopus 로고
    • Facilitating adverse drug event detection in pharmacovigilance databases using molecular structure similarity: Application to rhabdomyolysis
    • 21946238 10.1136/amiajnl-2011-000417
    • Vilar S, Harpaz R, Chase HS, et al. Facilitating adverse drug event detection in pharmacovigilance databases using molecular structure similarity: application to rhabdomyolysis. J Am Med Inform Assoc. 2011;18(Suppl. 1):i73-80.
    • (2011) J Am Med Inform Assoc , vol.18 , Issue.SUPPL. 1
    • Vilar, S.1    Harpaz, R.2    Chase, H.S.3
  • 37
    • 38849147881 scopus 로고    scopus 로고
    • Detection and reporting of drug-induced proarrhythmias: Room for improvement
    • Darpö B. Detection and reporting of drug-induced proarrhythmias: room for improvement. Europace. 2007;9 Suppl. 4:iv23-36.
    • (2007) Europace , vol.9 , Issue.SUPPL. 4
    • Darpö, B.1
  • 38
    • 0028217680 scopus 로고
    • Temafloxacin syndrome: Review of 95 cases
    • 8086558 10.1093/clinids/18.6.946 1:STN:280:DyaK2czmvV2mug%3D%3D
    • Blum MD, Graham DJ, McCloskey CA. Temafloxacin syndrome: review of 95 cases. Clin Infect Dis. 1994;18(6):946-50.
    • (1994) Clin Infect Dis , vol.18 , Issue.6 , pp. 946-950
    • Blum, M.D.1    Graham, D.J.2    McCloskey, C.A.3
  • 39
    • 22144474788 scopus 로고    scopus 로고
    • Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: The importance of reporting suspected reactions
    • 15983284 10.1001/archinte.165.12.1363
    • Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Arch Intern Med. 2005;165(12):1363-9.
    • (2005) Arch Intern Med , vol.165 , Issue.12 , pp. 1363-1369
    • Wysowski, D.K.1    Swartz, L.2
  • 40
    • 84876514249 scopus 로고    scopus 로고
    • US Food and Drug Administration Accessed 18 Oct
    • US Food and Drug Administration. FDA announces withdrawal fenfluramine and dexfenfluramine. Available from URL: http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm179871.htm. Accessed 18 Oct 2011.
    • (2011) FDA Announces Withdrawal Fenfluramine and Dexfenfluramine
  • 41
    • 0029131563 scopus 로고
    • Flucloxacillin hepatitis: An Australian epidemic
    • 10.1111/j.1445-5994.1995.tb01520.x 1:STN:280:DyaK28%2FnvVensQ%3D%3D
    • Desmond P. Flucloxacillin hepatitis: an Australian epidemic. Aust NZ J Med. 1995;25(3):195-6.
    • (1995) Aust NZ J Med , vol.25 , Issue.3 , pp. 195-196
    • Desmond, P.1
  • 42
    • 34447508333 scopus 로고    scopus 로고
    • Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: Data from spontaneous reporting in Italy
    • 17449881 10.1093/jac/dkm111 1:CAS:528:DC%2BD2sXot1ertr8%3D
    • Salvo F, Polimeni G, Moretti U, et al. Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: data from spontaneous reporting in Italy. J Antimicrob Chemother. 2007;60(1):121-6.
    • (2007) J Antimicrob Chemother , vol.60 , Issue.1 , pp. 121-126
    • Salvo, F.1    Polimeni, G.2    Moretti, U.3
  • 43
    • 0028999746 scopus 로고
    • Risk factors for the development of amoxycillin-clavulanic acid associated jaundice
    • 7603374 1:STN:280:DyaK2Mzis12ruw%3D%3D
    • Thomson JA, Fairley CK, Ugoni AM, et al. Risk factors for the development of amoxycillin-clavulanic acid associated jaundice. Med J Aust. 1995;162(12):638-40.
    • (1995) Med J Aust , vol.162 , Issue.12 , pp. 638-640
    • Thomson, J.A.1    Fairley, C.K.2    Ugoni, A.M.3
  • 44
    • 34548519302 scopus 로고    scopus 로고
    • Withdrawal of rotavirus vaccine recommendation
    • Withdrawal of rotavirus vaccine recommendation. MMWR Morb Mortal Wkly Rep. 1999;48(43):1007.
    • (1999) MMWR Morb Mortal Wkly Rep. , vol.48 , Issue.43 , pp. 1007
  • 45
    • 0033575158 scopus 로고    scopus 로고
    • Intussusception among recipients of rotavirus vaccine: United States, 1998-1999
    • Intussusception among recipients of rotavirus vaccine: United States, 1998-1999. MMWR Morb Mortal Wkly Rep. 1999;48(27):577-81.
    • (1999) MMWR Morb Mortal Wkly Rep. , vol.48 , Issue.27 , pp. 577-581
  • 46
    • 0035931959 scopus 로고    scopus 로고
    • Intussusception among infants given an oral rotavirus vaccine
    • 11207352 10.1056/NEJM200102223440804 1:STN:280:DC%2BD3M7ksVegug%3D%3D
    • Murphy TV, Gargiullo PM, Massoudi MS, et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med. 2001;344(8):564-72.
    • (2001) N Engl J Med , vol.344 , Issue.8 , pp. 564-572
    • Murphy, T.V.1    Gargiullo, P.M.2    Massoudi, M.S.3
  • 47
    • 0035860576 scopus 로고    scopus 로고
    • Data mining in the US Vaccine Adverse Event Reporting System (VAERS): Early detection of intussusception and other events after rotavirus vaccination
    • 11535310 10.1016/S0264-410X(01)00237-7 1:STN:280:DC%2BD3MvptlOktA%3D%3D
    • Niu MT, Erwin DE, Braun MM. Data mining in the US Vaccine Adverse Event Reporting System (VAERS): early detection of intussusception and other events after rotavirus vaccination. Vaccine. 2001;19(32):4627-34.
    • (2001) Vaccine , vol.19 , Issue.32 , pp. 4627-4634
    • Niu, M.T.1    Erwin, D.E.2    Braun, M.M.3
  • 48
    • 33750601209 scopus 로고    scopus 로고
    • Update: Guillain-Barre syndrome among recipients of Menactra meningococcal conjugate vaccine: United States
    • June 2005-September 2006
    • Update: Guillain-Barre syndrome among recipients of Menactra meningococcal conjugate vaccine: United States, June 2005-September 2006. MMWR Morb Mortal Wkly Rep. 2006;55(41):1120-4.
    • (2006) MMWR Morb Mortal Wkly Rep. , vol.55 , Issue.41 , pp. 1120-1124
  • 49
    • 33646744337 scopus 로고    scopus 로고
    • Under-reporting of adverse drug reactions: A systematic review
    • 16689555 10.2165/00002018-200629050-00003
    • Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385-96.
    • (2006) Drug Saf , vol.29 , Issue.5 , pp. 385-396
    • Hazell, L.1    Shakir, S.A.2
  • 50
    • 0033549087 scopus 로고    scopus 로고
    • The safety of newly approved medicines: Do recent market removals mean there is a problem?
    • 10328074 10.1001/jama.281.18.1728 1:STN:280:DyaK1M3lvVKhtA%3D%3D
    • Friedman MA, Woodcock J, Lumpkin MM, et al. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA. 1999;281(18):1728-34.
    • (1999) JAMA , vol.281 , Issue.18 , pp. 1728-1734
    • Friedman, M.A.1    Woodcock, J.2    Lumpkin, M.M.3
  • 51
    • 84876551718 scopus 로고    scopus 로고
    • Accessed 11 Nov 2011
    • Merck pulls arthritis drug Vioxx from market. Available from URL: http://www.npr.org/templates/story/story.php?storyId=4054991. Accessed 11 Nov 2011.
    • Merck Pulls Arthritis Drug Vioxx from Market
  • 52
    • 33846642973 scopus 로고    scopus 로고
    • What have we learnt from Vioxx?
    • 17235089 10.1136/bmj.39024.487720.68
    • Krumholz HM, Ross JS, Presler AH, et al. What have we learnt from Vioxx? BMJ. 2007;334(7585):120-3.
    • (2007) BMJ , vol.334 , Issue.7585 , pp. 120-123
    • Krumholz, H.M.1    Ross, J.S.2    Presler, A.H.3
  • 53
    • 0032417803 scopus 로고    scopus 로고
    • Limitations and strengths of spontaneous reports data
    • Goldman S. Limitations and strengths of spontaneous reports data. Clin Ther. 1998;20 Suppl. C:C40-4.
    • (1998) Clin Ther. , vol.20 , Issue.SUPPL. 3
    • Goldman, S.1
  • 54
    • 0034748578 scopus 로고    scopus 로고
    • How the US Food and Drug Administration defines and detects adverse drug events
    • 10.1016/S0011-393X(01)80070-9 1:CAS:528:DC%2BD3MXosF2rsrk%3D
    • Trontell A. How the US Food and Drug Administration defines and detects adverse drug events. Curr Ther Res. 2001;62:641-9.
    • (2001) Curr Ther Res , vol.62 , pp. 641-649
    • Trontell, A.1
  • 55
    • 78549253881 scopus 로고    scopus 로고
    • An experimental investigation of masking in the US FDA adverse event reporting system database
    • 21077702 10.2165/11584390-000000000-00000
    • Wang HW, Hochberg AM, Pearson RK, et al. An experimental investigation of masking in the US FDA adverse event reporting system database. Drug Saf. 2010;33(12):1117-33.
    • (2010) Drug Saf , vol.33 , Issue.12 , pp. 1117-1133
    • Wang, H.W.1    Hochberg, A.M.2    Pearson, R.K.3
  • 56
    • 84876547259 scopus 로고    scopus 로고
    • Institute of Medicine Accessed 20 Oct 2011
    • Institute of Medicine. The future of drug safety: promoting and protecting the health of the public. Available from URL: http://www.iom.edu/ Reports/2006/The-Future-of-Drug-Safety-Promoting-and-Protecting-the-Health-of- the-Public.aspx. Accessed 20 Oct 2011.
    • The Future of Drug Safety: Promoting and Protecting the Health of the Public
  • 57
    • 33750284204 scopus 로고    scopus 로고
    • Protecting the health of the public: Institute of Medicine recommendations on drug safety
    • 17030843 10.1056/NEJMp068228 1:CAS:528:DC%2BD28XhtFCis7%2FL
    • Psaty BM, Burke SP. Protecting the health of the public: Institute of Medicine recommendations on drug safety. N Engl J Med. 2006;355(17):1753-5.
    • (2006) N Engl J Med , vol.355 , Issue.17 , pp. 1753-1755
    • Psaty, B.M.1    Burke, S.P.2
  • 58
    • 33645213872 scopus 로고    scopus 로고
    • Use of health care databases in pharmacoepidemiology
    • 16611207 10.1111/j.1742-7843.2006.pto-368.x 1:CAS:528: DC%2BD28XjsVWmsLc%3D
    • Hennessy S. Use of health care databases in pharmacoepidemiology. Basic Clin Pharmacol Toxicol. 2006;98(3):311-3.
    • (2006) Basic Clin Pharmacol Toxicol , vol.98 , Issue.3 , pp. 311-313
    • Hennessy, S.1
  • 59
    • 7144259074 scopus 로고    scopus 로고
    • Use of the UK General Practice Research Database for pharmacoepidemiology
    • 9643612 10.1046/j.1365-2125.1998.00701.x 1:STN:280:DyaK1czgsFOltw%3D%3D
    • Garcia Rodriguez LA, Perez Gutthann S. Use of the UK General Practice Research Database for pharmacoepidemiology. Br J Clin Pharmacol. 1998;45(5):419-25.
    • (1998) Br J Clin Pharmacol , vol.45 , Issue.5 , pp. 419-425
    • Garcia Rodriguez, L.A.1    Perez Gutthann, S.2
  • 60
    • 36549071661 scopus 로고    scopus 로고
    • Primer: Administrative health databases in observational studies of drug effects - Advantages and disadvantages
    • 18037932 10.1038/ncprheum0652 1:CAS:528:DC%2BD2sXhtlCqsrzK
    • Suissa S, Garbe E. Primer: administrative health databases in observational studies of drug effects - advantages and disadvantages. Nat Clin Pract Rheumatol. 2007;3(12):725-32.
    • (2007) Nat Clin Pract Rheumatol , vol.3 , Issue.12 , pp. 725-732
    • Suissa, S.1    Garbe, E.2
  • 61
    • 0035067033 scopus 로고    scopus 로고
    • Population-based study of rotavirus vaccination and intussusception
    • 11332666 10.1097/00006454-200104000-00008 1:STN:280: DC%2BD3MvkvVaktw%3D%3D
    • Kramarz P, France EK, Destefano F, et al. Population-based study of rotavirus vaccination and intussusception. Pediatr Infect Dis J. 2001;20(4):410-6.
    • (2001) Pediatr Infect Dis J , vol.20 , Issue.4 , pp. 410-416
    • Kramarz, P.1    France, E.K.2    Destefano, F.3
  • 62
    • 78149349684 scopus 로고    scopus 로고
    • US FDA Accessed 12 Jul 2011
    • US FDA. The FDA Sentinel initiative. Available from URL: http://www.fda.gov/Safety/FDAsSentinelInitiative. Accessed 12 Jul 2011.
    • The FDA Sentinel Initiative
  • 63
    • 84876550856 scopus 로고    scopus 로고
    • Mini-Sentinel Accessed 15 Feb 2011
    • Mini-Sentinel. Available from URL: http://mini-sentinel.org/ Accessed 15 Feb 2011.
  • 64
    • 84876557536 scopus 로고    scopus 로고
    • Mini-Sentinel Accessed 31 May 2012
    • Mini-Sentinel. Statistical methods development. Available from URL: http://mini-sentinel.org/methods/methods-development/default.aspx. Accessed 31 May 2012.
    • Statistical Methods Development
  • 65
    • 78751688048 scopus 로고    scopus 로고
    • Advancing the science for active surveillance: Rationale and design for the Observational Medical Outcomes Partnership
    • 21041580
    • Stang PE, Ryan PB, Racoosin JA, et al. Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med. 2010;153(9):600-6.
    • (2010) Ann Intern Med , vol.153 , Issue.9 , pp. 600-606
    • Stang, P.E.1    Ryan, P.B.2    Racoosin, J.A.3
  • 66
    • 84876580160 scopus 로고    scopus 로고
    • Observational Medical Outcomes Partnership Accessed 11 Nov 2011
    • Observational Medical Outcomes Partnership. Health outcomes of interest library. Available from URL: http://omop.fnih.org/HOI. Accessed 11 Nov 2011.
    • Health Outcomes of Interest Library
  • 67
    • 84876555631 scopus 로고    scopus 로고
    • Observational Medical Outcomes Partnership. OMOP Cup 2010 Accessed 10 Oct 2011
    • Observational Medical Outcomes Partnership. OMOP Cup 2010. Available from URL: http://omop.fnih.org/omopcup. Accessed 10 Oct 2011.
  • 68
    • 84876580068 scopus 로고    scopus 로고
    • Observational Medical Outcomes Partnership Accessed 30 Mar 2012
    • Observational Medical Outcomes Partnership. OMOP 2011 symposium presentations. Available from URL: http://omop.fnih.org/OMOP2011Symposium. Accessed 30 Mar 2012.
    • OMOP 2011 Symposium Presentations
  • 69
    • 84876541990 scopus 로고    scopus 로고
    • Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical records and Biomedical Knowledge. The EU-ADR Project Accessed 12 Jul 2011
    • Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical records and Biomedical Knowledge. The EU-ADR Project. Available from URL: http://www.euadr-project.org. Accessed 12 Jul 2011.
  • 70
    • 72449176909 scopus 로고    scopus 로고
    • Data mining on electronic health record databases for signal detection in pharmacovigilance: Which events to monitor?
    • 19757412 10.1002/pds.1836
    • Trifiro G, Pariente A, Coloma PM, et al. Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiol Drug Saf. 2009;18(12):1176-84.
    • (2009) Pharmacoepidemiol Drug Saf , vol.18 , Issue.12 , pp. 1176-1184
    • Trifiro, G.1    Pariente, A.2    Coloma, P.M.3
  • 71
    • 84862932391 scopus 로고    scopus 로고
    • The US Food and Drug Administration's Mini-Sentinel program: Status and direction
    • 22262586
    • Platt R, Carnahan RM, Brown JS, et al. The US Food and Drug Administration's Mini-Sentinel program: status and direction. Pharmacoepidemiol Drug Saf. 2012;21(Suppl. 1):1-8.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.SUPPL. 1 , pp. 1-8
    • Platt, R.1    Carnahan, R.M.2    Brown, J.S.3
  • 72
    • 84876553663 scopus 로고    scopus 로고
    • Canadian Institutes of Health Research Accessed Mar 2012
    • Canadian Institutes of Health Research. About the drug safety effectiveness network. Available from URL: http://www.cihr-irsc.gc.ca/e/40269. html. Accessed Mar 2012.
    • About the Drug Safety Effectiveness Network
  • 73
    • 84876550779 scopus 로고    scopus 로고
    • Innovative Medicines Initiative. PROTECT project Accessed Mar 2012
    • Innovative Medicines Initiative. PROTECT project. Available from URL: http://www.imi-protect.eu/. Accessed Mar 2012.
  • 74
    • 84876566170 scopus 로고    scopus 로고
    • Accessed 10 May 2012
    • Global Research in Paediatrics. Available from URL: http://www.grip- network.org/. Accessed 10 May 2012.
    • Global Research in Paediatrics
  • 75
    • 81955164831 scopus 로고    scopus 로고
    • Pharmacovigilance systems and databases in Korea, Japan, and Taiwan
    • 21936017 10.1002/pds.2244
    • Kimura T, Matsushita Y, Yang YH, et al. Pharmacovigilance systems and databases in Korea, Japan, and Taiwan. Pharmacoepidemiol Drug Saf. 2011;20(12):1237-45.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , Issue.12 , pp. 1237-1245
    • Kimura, T.1    Matsushita, Y.2    Yang, Y.H.3
  • 76
    • 77649227661 scopus 로고    scopus 로고
    • Signal detection of rosuvastatin compared to other statins: Data-mining study using national health insurance claims database
    • 20049851 10.1002/pds.1902 1:CAS:528:DC%2BC3cXks1Sgsb0%3D
    • Choi NK, Chang Y, Choi YK, et al. Signal detection of rosuvastatin compared to other statins: data-mining study using national health insurance claims database. Pharmacoepidemiol Drug Saf. 2010;19(3):238-46.
    • (2010) Pharmacoepidemiol Drug Saf , vol.19 , Issue.3 , pp. 238-246
    • Choi, N.K.1    Chang, Y.2    Choi, Y.K.3
  • 77
    • 70350771237 scopus 로고    scopus 로고
    • Talkin' about a revolution": How electronic health records can facilitate the scale-up of HIV care and treatment and catalyze primary care in resource-constrained settings
    • 19858941 10.1097/QAI.0b013e3181bbcb67
    • Braitstein P, Einterz RM, Sidle JE, et al. "Talkin' about a revolution": how electronic health records can facilitate the scale-up of HIV care and treatment and catalyze primary care in resource-constrained settings. J Acquir Immune Defic Syndr. 2009;52(Suppl. 1):S54-7.
    • (2009) J Acquir Immune Defic Syndr , vol.52 , Issue.SUPPL. 1
    • Braitstein, P.1    Einterz, R.M.2    Sidle, J.E.3
  • 78
    • 78649527179 scopus 로고    scopus 로고
    • Experience implementing electronic health records in three East African countries
    • 20841711
    • Tierney WM, Achieng M, Baker E, et al. Experience implementing electronic health records in three East African countries. Stud Health Technol Inform. 2010;160(Pt 1):371-5.
    • (2010) Stud Health Technol Inform , vol.160 , Issue.PART 1 , pp. 371-375
    • Tierney, W.M.1    Achieng, M.2    Baker, E.3
  • 79
    • 78650459029 scopus 로고    scopus 로고
    • Vaccination coverage among children under two years of age based on electronic immunization registry in Southern Brazil
    • 21152707 10.1590/S0034-89102010005000054
    • Luhm KR, Cardoso MR, Waldman EA. Vaccination coverage among children under two years of age based on electronic immunization registry in Southern Brazil. Rev Saude Publica. 2011;45(1):90-8.
    • (2011) Rev Saude Publica , vol.45 , Issue.1 , pp. 90-98
    • Luhm, K.R.1    Cardoso, M.R.2    Waldman, E.A.3
  • 80
    • 84876559815 scopus 로고    scopus 로고
    • Knowledge finding in IMS disease analyzer Mediplus UK database: Effective data mining in longitudinal patient safety data
    • Dublin; 6-8 Oct
    • Bate A, Edwards IR, Edwards J, et al. Knowledge finding in IMS disease analyzer Mediplus UK database: effective data mining in longitudinal patient safety data. ISOP Annual Meeting: Pharmacovigilance - Current and Future Challenges, Dublin; 6-8 Oct 2004.
    • (2004) ISOP Annual Meeting: Pharmacovigilance - Current and Future Challenges
    • Bate, A.1    Edwards, I.R.2    Edwards, J.3
  • 81
    • 50949096623 scopus 로고    scopus 로고
    • Adaptation of Bayesian data mining algorithms to longitudinal claims data: Coxib safety as an example
    • 18725852 10.1097/MLR.0b013e318179253b
    • Curtis J, Cheng H, Delzell E, et al. Adaptation of Bayesian data mining algorithms to longitudinal claims data: coxib safety as an example. Med Care. 2008;46(9):969-75.
    • (2008) Med Care , vol.46 , Issue.9 , pp. 969-975
    • Curtis, J.1    Cheng, H.2    Delzell, E.3
  • 82
    • 65349157361 scopus 로고    scopus 로고
    • Active computerized pharmacovigilance using natural language processing, statistics, and electronic health records: A feasibility study
    • 19261932 10.1197/jamia.M3028
    • Wang X, Hripcsak G, Markatou M, et al. Active computerized pharmacovigilance using natural language processing, statistics, and electronic health records: a feasibility study. J Am Med Inform Assoc. 2009;16(3):328-37.
    • (2009) J Am Med Inform Assoc , vol.16 , Issue.3 , pp. 328-337
    • Wang, X.1    Hripcsak, G.2    Markatou, M.3
  • 83
    • 77957796468 scopus 로고    scopus 로고
    • Temporal data mining for adverse events following immunization in nationwide Danish healthcare databases
    • 20925439 10.2165/11537630-000000000-00000
    • Svanstrom H, Callreus T, Hviid A. Temporal data mining for adverse events following immunization in nationwide Danish healthcare databases. Drug Saf. 2010;33(11):1015-25.
    • (2010) Drug Saf , vol.33 , Issue.11 , pp. 1015-1025
    • Svanstrom, H.1    Callreus, T.2    Hviid, A.3
  • 84
    • 59649118761 scopus 로고    scopus 로고
    • A distributed research network model for post-marketing safety studies: The Meningococcal Vaccine Study
    • 18956428 10.1002/pds.1675
    • Velentgas P, Bohn RL, Brown JS, et al. A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study. Pharmacoepidemiol Drug Saf. 2008;17(12):1226-34.
    • (2008) Pharmacoepidemiol Drug Saf , vol.17 , Issue.12 , pp. 1226-1234
    • Velentgas, P.1    Bohn, R.L.2    Brown, J.S.3
  • 85
    • 34848826898 scopus 로고    scopus 로고
    • Real-time vaccine safety surveillance for the early detection of adverse events
    • Lieu TA, Kulldorff M, Davis RL, et al. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care. 2007;45(10 Suppl. 2):S89-95.
    • (2007) Med Care. , vol.45 , Issue.10 SUPPL. 2
    • Lieu, T.A.1    Kulldorff, M.2    Davis, R.L.3
  • 86
    • 79951975416 scopus 로고    scopus 로고
    • Methods for drug safety signal detection in longitudinal observational databases: LGPS and LEOPARD
    • 20945505 10.1002/pds.2051 1:CAS:528:DC%2BC3MXks1KitLk%3D
    • Schuemie MJ. Methods for drug safety signal detection in longitudinal observational databases: LGPS and LEOPARD. Pharmacoepidemiol Drug Saf. 2011;20(3):292-9.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , Issue.3 , pp. 292-299
    • Schuemie, M.J.1
  • 87
    • 81355127388 scopus 로고    scopus 로고
    • Temporal pattern discovery in longitudinal electronic patient records
    • 10.1007/s10618-009-0152-3
    • Noren GN, Hopstadius J, Bate A, et al. Temporal pattern discovery in longitudinal electronic patient records. Data Min Knowl Disc. 2010;20:361-87.
    • (2010) Data Min Knowl Disc , vol.20 , pp. 361-387
    • Noren, G.N.1    Hopstadius, J.2    Bate, A.3
  • 88
    • 84876540588 scopus 로고    scopus 로고
    • Observational Medical Outcomes Partnership Accessed 20 May 2012
    • Observational Medical Outcomes Partnership. OMOP methods library. Available from URL: http://omop.fnih.org/Methods. Accessed 20 May 2012.
    • OMOP Methods Library
  • 89
    • 84861348570 scopus 로고    scopus 로고
    • Disproportionality methods for pharmacovigilance in longitudinal observational databases
    • [Epub ahead of print]
    • Zorych I, Madigan D, Ryan P, et al. Disproportionality methods for pharmacovigilance in longitudinal observational databases. Stat Methods Med Res. 2011 [Epub ahead of print].
    • (2011) Stat Methods Med Res.
    • Zorych, I.1    Madigan, D.2    Ryan, P.3
  • 90
    • 84876582946 scopus 로고    scopus 로고
    • Comparison of methods for drug safety signal detection using electronic healthcare record (EHR) databases: The added value of longitudinal, time-stamped patient information
    • Chicago; 14-17 Aug 2011
    • Coloma P, Schuemie MJ, Trifiro G, et al. Comparison of methods for drug safety signal detection using electronic healthcare record (EHR) databases: the added value of longitudinal, time-stamped patient information. Presented at the 27th international conference on pharmacoepidemiology and therapeutic risk management, Chicago; 14-17 Aug 2011.
    • 27th International Conference on Pharmacoepidemiology and Therapeutic Risk Management
    • Coloma, P.1    Schuemie, M.J.2    Trifiro, G.3
  • 91
    • 84866563491 scopus 로고    scopus 로고
    • Using electronic healthcare records for drug safety signal detection: A comparative evaluation of statistical methods
    • 22929992 10.1097/MLR.0b013e31825f63bf
    • Schuemie MJ, Coloma PM, Straatman H, et al. Using electronic healthcare records for drug safety signal detection: a comparative evaluation of statistical methods. Med Care. 2012;50:890-7.
    • (2012) Med Care , vol.50 , pp. 890-897
    • Schuemie, M.J.1    Coloma, P.M.2    Straatman, H.3
  • 92
    • 84861122386 scopus 로고    scopus 로고
    • Automatic filtering and substantiation of drug safety signals
    • 22496632 10.1371/journal.pcbi.1002457 1:CAS:528:DC%2BC38Xlslejt7w%3D
    • Bauer-Mehren A, van Mullingen EM, Avillach P, et al. Automatic filtering and substantiation of drug safety signals. PLoS Comput Biol. 2012;8(4):e1002457.
    • (2012) PLoS Comput Biol , vol.8 , Issue.4 , pp. 1002457
    • Bauer-Mehren, A.1    Van Mullingen, E.M.2    Avillach, P.3
  • 93
    • 18044398603 scopus 로고    scopus 로고
    • A review of uses of health care utilization databases for epidemiologic research on therapeutics
    • 15862718 10.1016/j.jclinepi.2004.10.012
    • Schneeweiss S, Avorn J. A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol. 2005;58(4):323-37.
    • (2005) J Clin Epidemiol , vol.58 , Issue.4 , pp. 323-337
    • Schneeweiss, S.1    Avorn, J.2
  • 94
    • 0023847702 scopus 로고
    • Accuracy of diagnostic coding for Medicare patients under the prospective-payment system
    • 3123929 10.1056/NEJM198802113180604 1:STN:280:DyaL1c7it1arsQ%3D%3D
    • Hsia DC, Krushat WM, Fagan AB, et al. Accuracy of diagnostic coding for Medicare patients under the prospective-payment system. N Engl J Med. 1988;318(6):352-5.
    • (1988) N Engl J Med , vol.318 , Issue.6 , pp. 352-355
    • Hsia, D.C.1    Krushat, W.M.2    Fagan, A.B.3
  • 95
    • 84859874348 scopus 로고    scopus 로고
    • Electronic healthcare databases for active drug safety surveillance: Is there enough leverage?
    • 22315152 10.1002/pds.3197
    • Coloma PM, Trifiro G, Schuemie MJ, et al. Electronic healthcare databases for active drug safety surveillance: is there enough leverage? Pharmacoepidemiol Drug Saf. 2012;21:611-21.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , pp. 611-621
    • Coloma, P.M.1    Trifiro, G.2    Schuemie, M.J.3
  • 96
    • 84876522440 scopus 로고    scopus 로고
    • Daily Med. Accessed 13 Jul 2011
    • Daily Med. Trovafloxacin drug label. Available from URL: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=442&CFID= 66575927&CFTOKEN=a17d753a0754a3fb-24987D34-D80B-CD9C- 39F668DB8C41A045&jsessionid=ca30e46b22b0112063a4. Accessed 13 Jul 2011.
    • Trovafloxacin Drug Label
  • 97
    • 84876570599 scopus 로고    scopus 로고
    • Daily Med Accessed 13 Jul 2011
    • Daily Med. Rosiglitazone drug label. Available from URL: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=38243. Accessed 13 Jul 2011.
    • Rosiglitazone Drug Label
  • 98
    • 84876586344 scopus 로고    scopus 로고
    • European Medicines Agency. Tysabri (natalizumab) Accessed 13 Jul 2011
    • European Medicines Agency. Tysabri (natalizumab). Available from URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/ 000603/human-med-001119.jsp&murl=menus/medicines/medicines.jsp&mid= WC0b01ac058001d124. Accessed 13 Jul 2011.
  • 99
    • 84876564614 scopus 로고    scopus 로고
    • MHRA Accessed 13 Jul 2011
    • MHRA. Dopamine agonists for Parkinson's disease. Available from URL: http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/ Product-specificinformationandadvice/Product-specificinformationandadvice-A-F/ DopamineagonistsforParkinson146sdisease/index.htm. Accessed 13 Jul 2011.
    • Dopamine Agonists for Parkinson's Disease
  • 100
    • 33748675101 scopus 로고    scopus 로고
    • European Commission Accessed 20 Apr 2012
    • European Commission. A guideline on summary of product characteristics. Available from URL: http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc- guideline-rev2-en.pdf. Accessed 20 Apr 2012.
    • A Guideline on Summary of Product Characteristics
  • 101
    • 0345257262 scopus 로고    scopus 로고
    • Joining the DoTS: New approach to classifying adverse drug reactions
    • 14630763 10.1136/bmj.327.7425.1222 1:STN:280:DC%2BD3srltVaisg%3D%3D
    • Aronson JK, Ferner RE. Joining the DoTS: new approach to classifying adverse drug reactions. BMJ. 2003;327(7425):1222-5.
    • (2003) BMJ , vol.327 , Issue.7425 , pp. 1222-1225
    • Aronson, J.K.1    Ferner, R.E.2
  • 102
    • 0002548545 scopus 로고
    • Pathogenesis of adverse drug reactions
    • Davies D, editor 3rd ed. Oxford: Oxford University Press
    • Rawlins MD, Thompson JW. Pathogenesis of adverse drug reactions. In: Davies D, editor. Textbook of adverse drug reactions. 3rd ed. Oxford: Oxford University Press; 1985.
    • (1985) Textbook of Adverse Drug Reactions
    • Rawlins, M.D.1    Thompson, J.W.2
  • 103
    • 23644441917 scopus 로고    scopus 로고
    • What are the real lessons from Vioxx?
    • 16048352 10.2165/00002018-200528080-00001 1:CAS:528:DC%2BD2MXhtVWjsLjF
    • Edwards IR. What are the real lessons from Vioxx? Drug Saf. 2005;28(8):651-8.
    • (2005) Drug Saf , vol.28 , Issue.8 , pp. 651-658
    • Edwards, I.R.1
  • 104
    • 0035092543 scopus 로고    scopus 로고
    • Evaluation of the characteristics of safety withdrawal of prescription drugs from worldwide pharmaceutical markets - 1960 to 1999
    • 10.1177/009286150103500134
    • Fung M, Thornton A, Mybeck K, et al. Evaluation of the characteristics of safety withdrawal of prescription drugs from worldwide pharmaceutical markets - 1960 to 1999. Drug Inf J. 2001;35:293-317.
    • (2001) Drug Inf J , vol.35 , pp. 293-317
    • Fung, M.1    Thornton, A.2    Mybeck, K.3
  • 105
    • 79960993889 scopus 로고    scopus 로고
    • EU-ADR healthcare database network vs. spontaneous reporting system database: Preliminary comparison of signal detection
    • 21685607
    • Trifiro G, Patadia V, Schuemie MJ, et al. EU-ADR healthcare database network vs. spontaneous reporting system database: preliminary comparison of signal detection. Stud Health Technol Inform. 2011;166:25-30.
    • (2011) Stud Health Technol Inform , vol.166 , pp. 25-30
    • Trifiro, G.1    Patadia, V.2    Schuemie, M.J.3
  • 106
    • 84856805878 scopus 로고    scopus 로고
    • A novel signal detection algorithm for identifying hidden drug-drug interactions in adverse event reports
    • 21676938 10.1136/amiajnl-2011-000214
    • Tatonetti NP, Fernald GH, Altman RB. A novel signal detection algorithm for identifying hidden drug-drug interactions in adverse event reports. J Am Med Inform Assoc. 2012;19(1):79-85.
    • (2012) J Am Med Inform Assoc , vol.19 , Issue.1 , pp. 79-85
    • Tatonetti, N.P.1    Fernald, G.H.2    Altman, R.B.3
  • 107
    • 0036300274 scopus 로고    scopus 로고
    • Signal selection and follow-up in pharmacovigilance
    • 12071784 10.2165/00002018-200225060-00011
    • Meyboom RH, Lindquist M, Egberts AC, et al. Signal selection and follow-up in pharmacovigilance. Drug Saf. 2002;25(6):459-65.
    • (2002) Drug Saf , vol.25 , Issue.6 , pp. 459-465
    • Meyboom, R.H.1    Lindquist, M.2    Egberts, A.C.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.